Dextrose Hydrodissection for Post-Breast Cancer Chest Wall and Axillary Tightness.

NCT07378319 | Recruiting DMC

• 1 other identifier: VGHTHU114122
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial (prospective case series) is to evaluate the feasibility, safety, and preliminary clinical outcomes of ultrasound-guided dextrose prolotherapy in female breast cancer survivors with persistent ipsilateral chest wall and axillary pain and tightness who have plateaued with standard physical therapy. The main questions it aims to answer are: Does ultrasound-guided dextrose prolotherapy significantly improve upper extremity functional limitation (measured by the QuickDASH questionnaire)? What are the effects of this intervention on pain intensity (NRS), active shoulder range of motion (AROM), and anterior chest wall soft-tissue tightness (pectoralis minor muscle length)? Participants will: Undergo a comprehensive baseline physical examination and ultrasound assessment of the symptomatic chest wall and axilla. Receive three sessions of ultrasound-guided 5% dextrose injections into targeted soft-tissue planes at 4-week intervals. Continue their designated standard rehabilitation program, including range-of-motion and stretching exercises. Attend follow-up assessments at 4-week intervals during the treatment phase, with long-term follow-up at 3 and 6 months after the final injection to evaluate the durability of the response.

Conditions

Breast Cancer Females

Keywords

breast cancer; dextrose injection

Outcome Measures

Primary Outcomes (1)

• Upper Extremity Function

  Upper extremity functional limitation was assessed using the QuickDASH questionnaire, with scores ranging from 0 (no disability) to 100 (most severe disability). The minimal clinically important difference (MCID) for the QuickDASH was defined as 15 points

  Baseline, 4 weeks after the 1st injection, 4 weeks after the 2nd injection, 4 weeks after the 3rd injection (approx. 12 weeks from baseline), 3 months after the 3rd injection and 6 months after the 3rd injection

Secondary Outcomes (3)

• Pain Intensity

  Baseline, 4 weeks after the 1st injection, 4 weeks after the 2nd injection, 4 weeks after the 3rd injection (approx. 12 weeks from baseline), 3 months after the 3rd injection and 6 months after the 3rd injection

• Shoulder Range of Motion

  Baseline, 4 weeks after the 1st injection, 4 weeks after the 2nd injection, 4 weeks after the 3rd injection (approx. 12 weeks from baseline), 3 months after the 3rd injection and 6 months after the 3rd injection

• Pectoralis Minor Length

  Baseline, 4 weeks after the 1st injection, 4 weeks after the 2nd injection, 4 weeks after the 3rd injection (approx. 12 weeks from baseline), 3 months after the 3rd injection , and 6 months after the 3rd injection

Other Outcomes (1)

• Patient Global Impression of Change

  4 weeks after the 1st injection, 4 weeks after the 2nd injection, 4 weeks after the 3rd injection (approx. 12 weeks from baseline), 3 months after the 3rd injection and 6 months after the 3rd injection

Study Arms (1)

Experimental Group

EXPERIMENTAL

Participants in this single experimental arm will receive three sessions of ultrasound-guided dextrose injections (e.g., 5% or 15% Dextrose) targeting symptomatic myofascial and interfascial planes of the ipsilateral chest wall and axilla, such as the pectoralis major-minor interface or axillary fascia. Injections are administered at 4-week intervals (at Baseline, Week 4, and Week 8). Throughout the 6-month study period, all participants continue their standardized rehabilitation program, which includes range-of-motion exercises, stretching of the chest wall and axillary musculature, and progressive strengthening.

Procedure: ultrasound guided dextrose prolotherapy

Interventions

ultrasound guided dextrose prolotherapy PROCEDURE

Participants receive three sessions of ultrasound-guided 5% dextrose injections into symptomatic myofascial and interfascial planes of the ipsilateral chest wall and axillary region. The technique involves identifying areas of soft-tissue thickening or restricted fascial glide under high-frequency ultrasound. Injection targets are individualized to each patient's specific site of restriction (e.g., clavipectoral fascia, pectoralis major-minor interface, or axillary fascia). Sessions are administered at 4-week intervals (at weeks 0, 4, and 8).

Experimental Group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• History of breast cancer surgery (mastectomy or breast-conserving surgery), with or without axillary lymph node dissection
• Persistent ipsilateral chest wall and/or axillary pain, tightness, or movement restriction lasting ≥ 3 months after surgery;
• Clinically significant baseline symptom severity, defined as Quick Disabilities of the Arm, Shoulder and Hand (QuickDASH) questionnaire ≥ 25 and/or pain intensity ≥ 5/10 on the Numeric Rating Scale (NRS);
• Completion of 12 weeks of standard physical therapy with no significant improvement, defined as a change in QuickDASH score from baseline to completion of therapy below the minimal clinically important difference (MCID; \<15 points ) and/or pain improvement \< 2 points on the NRS .
• Age ≥ 18 years;
• Ability to provide written informed consent.

You may not qualify if:

• Evidence of local cancer recurrence or metastatic disease;
• Active lymphedema requiring ongoing decongestive therapy at the time of enrollment;
• Shoulder pathology, including intra-articular or peri-articular conditions (e.g., adhesive capsulitis with marked capsular restriction, or acute rotator cuff tear,) judged by clinical assessment to be the dominant cause of symptoms.
• Active infection, skin lesion, or unhealed surgical wound at the intended injection site;
• Known bleeding disorders or anticoagulant use contraindicating injection;
• Known allergy to dextrose or any components of the injection protocol;
• Pregnancy or other medical conditions precluding participation.

Sponsors & Collaborators

• Taichung Veterans General Hospital: lead

Study Sites (1)

Taichung Veterans Genetal Hospital

Taichung, Taiwan, 407, Taiwan

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Yuchun Lee, M.D.

  Taichung Veterans General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yuchun Lee, M.D.

CONTACT

886423592525; lyczoj@vghtc.gov.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This study utilizes a prospective, single-arm, interventional model (Single Group Assignment) designed as a pilot case series. The design focuses on evaluating the within-subject changes in functional and pain-related outcomes following a standardized interventional protocol.

Study Record Dates

• First Submitted: January 15, 2026
• First Posted: January 30, 2026
• Study Start: January 11, 2025
• Primary Completion: February 1, 2026
• Study Completion (Estimated): June 28, 2026
• Last Updated: March 20, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Data will be available beginning 6 months and ending 3 years following article publication.
• Access Criteria: Data will be shared with researchers who provide a methodologically sound proposal. Proposals should be directed to the corresponding author. To gain access, data requestors will need to sign a data access agreement.

Locations

TW (1)